Depomed gets favorable patent ruling in US for NUCYNTA ANDAs

Judge Claire C. Cecchi of the United States District Court for the District of New Jersey has ruled in favor of Depomed in the company’s patent litigation against all three filers of Abbreviated New Drug Applications (ANDAs) for Depomed’s NUCYNTA franchise.

With the court’s ruling, Depomed expects market exclusivity until December 2025 for NUCYNTA ER, NUCYNTA and NUCYNTA oral solution (an unmarketed form of NUCYNTA).

Jim Schoeneck, President and CEO of Depomed, said: “We are pleased with the Court’s decision as it confirms the validity and strength of the NUCYNTA patents.

“We look forward to growing the NUCYNTA franchise, comprised of two important and highly-differentiated medicines, for at least the next 9 years.”

The court found U.S. patent Nos. 7,994,364 and RE39,593 to be valid and infringed by the defendants.  The patents cover the entire NUCYNTA franchise and will expire on December 27, 2025 and February 5, 2023, respectively.

Judge Cecchi upheld the validity of U.S. Patent No. 8,536,130 (the “130 Patent”), but found that two of the three filers do not infringe the patent.  The ‘130 Patent covers NUCYNTA ER until March 2029.

The company intends to appeal the court’s finding as it relates to infringement of the ‘130 Patent.

The defendants in the litigation included Actavis Inc., Alkem Laboratories Limited and Roxane Laboratories, Inc., along with certain of their affiliated companies.  All three defendants filed ANDAs for NUCYNTA ER and NUCYNTA.  An affiliate of Actavis filed an ANDA for NUCYNTA oral solution.